988957

Generitech Corporation — FEI 3002994577

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 6, 2016
Fiscal Year
2017
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Fresno, CA (United States)

Citations

IDCFRDescription
1545621 CFR 111.20(b)Physical plant - space; equipment, materials
1549221 CFR 111.25(a)Procedures - calibrating instruments
1549621 CFR 111.27(b)Instruments - calibration
1553221 CFR 111.255(b)Batch record - complete
1570221 CFR 111.320(b)Examination, testing; scientifically valid
1573221 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
1573621 CFR 111.353Manufacturing operations - written procedures
1573721 CFR 111.210(h)(5)Corrective action plans
1574421 CFR 111.210(h)(2)Master manufacturing record - sampling, tests, examinations
1574721 CFR 111.210(g)Packaging description, representative label
1574821 CFR 111.210(f)Master manufacturing record theoretical and expected yield
1575221 CFR 111.210(c)Master manufacturing record - components; weight, measure
1575321 CFR 111.210(b)Master manufacturing record - list components
1575421 CFR 111.210(a)Master manufacturing record - dietary ingredients
1576221 CFR 111.205(a)Master manufacturing record - each batch
1582821 CFR 111.70(a)Specifications - manufacturing process
1583021 CFR 111.70(b)(2)Specifications-component purity, strength, composition
1583821 CFR 111.70(d)Specifications - labels, packaging
1585321 CFR 111.73Specifications met - identity, purity, strength, composition
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1586321 CFR 111.75(a)(2)(ii)(B)Component - certificate of analysis
1587121 CFR 111.75(c)(2)Specifications met - test, examinations; compliance
1592221 CFR 111.95(b)(3)Documentation - ensure specifications met
1592321 CFR 111.95(b)(4)Documentation - specifications met; test, examinations
1595421 CFR 111.113(a)(2)Quality control master manufacturing record; material review, disposition
451521 CFR 108.35(c)(2)Process filing